Application 203174
- Type
- ANDA
- Sponsor
- BIONPHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BEXAROTENE | BEXAROTENE | CAPSULE;ORAL | 75MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-6955 | Bexarotene | Bexarotene | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-6955 | Bexarotene | Bexarotene | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 42292-007 | Bexarotene | Bexarotene | Mylan Institutional Inc. | ANDA | Current |
| 42292-007 | Bexarotene | Bexarotene | Mylan Institutional Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58925 | ORIG | 2019-06-03 |